依巴斯汀原料药及其片剂有关物质测定方法的改进

Improved Determination Method of Related Substances in Ebastine and Ebastine Tablets

摘要: 目的改进依巴斯汀原料药及其片剂有关物质的测定方法。方法色谱柱采用YMC-pack ODS-A C₁₈色谱柱(150 mm×4.6 mm，5 μm)，乙腈-磷酸盐缓冲液(pH 7.0)(75∶25)为流动相，柱温为35 ℃，流速为1.0 mL?min^-1，检测波长为210 nm。结果所建立色谱条件可有效检测出依巴斯汀原料药和片剂中杂质，杂质C和杂质D的检出限均为0.11 μg?mL^-1，其校正因子均为1.4。结论该方法测定依巴斯汀及其片剂有关物质简便、专属性强，测定结果准确可靠。

Abstract: OBJECTIVE To improve the method of related substances determination of ebastine and ebastine tablets. METHODS Chromatography was carried on YMC-pack ODS-A C₁₈ column (150 mm×4.6 mm, 5 μm) with the column temperature at 35 ℃, using the acetonitrile-phosphate buffer (pH 7.0) as the mobile phase at a flow rate of 1.0 mL?min^-1. the detective wavelength was set at 210 nm. RESULTS The method was effective for determination of related substance in ebastine and ebastine tablets. The detection limit and the calibration factor both of impurity C and impurity D were 0.11 μg?mL^-1 and 1.4 respectively. CONCLUSION The method proposed for determining the related substances determination of ebastine and ebastine tablets is quick, accurate and reliable.